FACTOR II (PROTHROMBIN) G20210A KIT— 510(k) K033612
Substantially EquivalentRoche Diagnostics Corp.
FDA 510(k) clearance K033612 for FACTOR II (PROTHROMBIN) G20210A KIT, Substantially Equivalent on 2003-12-18. Applicant: Roche Diagnostics Corp.. Device class: 2.
Clearance details
- Applicant
- Roche Diagnostics Corp.
- Product code
- Code NPR
- Device class
- Class 2
- Regulation
- 21 CFR 864.7280
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
Recent devices under product code NPR
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